Specialist II Medical Data - Brussels - 12 Months+

PROJECT LENGTH: 12 months+

LOCATION: Brussels

START DATE: ASAP

TITLE: Clinical Data Manager

My Client based in Brussels is an international company leader in his/her sector.

PURPOSE STATEMENT

Medical Data Specialists are responsible for ensuring the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and edit checks, as well as the review of clinical data for completeness, accuracy, and consistency. Medical Data Specialists achieve this through collaboration with clinical colleagues (eg, Project Management, Trial Operations, Site Operations, Clinical IS, Global Safety, Biostatistics, Quality and Medical Sciences) and other cross functional team members (eg, Legal and Regulatory).

KEY RESPONSIBILITIES

- Review clinical data for completeness, accuracy and consistency in accordance with the investigational plan.
- Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
- Provide subject matter expertise to project team members during all phases of project life cycle.
- Provides accurate and timely clinical data to internal and external customers upon request.
- Develop, test, and maintain data management systems.
- Provide subject matter expertise prior, during and post internal and external audits and inspections.
- Maintaincompliance with corporate, core and study-specific learning requirements.

QUALITY SYSTEM REQUIREMENTS

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.

JOB SCOPE AND LEVELING GUIDELINES

KNOWLEDGE

A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

PROBLEM SOLVING

Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

PLANNING AND ORGANIZATION

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

DISCRETION/LATITUDE; SUPERVISION RECEIVED; DECISION MAKING

Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.

BUSINESS RELATIONSHIP AND PROJECT MANAGEMENT

Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

IMPACT

Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.

LIAISON

Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.

MENTORING

Provides guidance to less experienced staff.

SKILLS REQUIRED:

MINIMUM EDUCATION & EXPERIENCE:

- Bachelor's-level degree required. Degree in science/health related field (eg Biology, Nursing or Biomedical) preferred.

COMPETENCY EXPECTATIONS:

- Good verbal and written communication skills.
- Excellent interpersonal and organizational skills.
- Detail oriented and good problem solving ability.
- Ability to work on teams and with multiple projects.
- Strong capacity for analysis and a structured mind.
- Excellent computer skills

Please send me your CV immediately at, I'll provide you with a necessary information to maximize the opportunity. We are based in Brussels!